SERTRALINE HYDROCHLORIDE is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Accord Healthcare, Inc.. The primary component is Sertraline Hydrochloride.
| Product ID | 16729-216_72d1f64f-958e-72bf-e053-2991aa0aaea5 |
| NDC | 16729-216 |
| Product Type | Human Prescription Drug |
| Proprietary Name | SERTRALINE HYDROCHLORIDE |
| Generic Name | Sertraline Hydrochloride |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2017-02-09 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA202825 |
| Labeler Name | Accord Healthcare, Inc. |
| Substance Name | SERTRALINE HYDROCHLORIDE |
| Active Ingredient Strength | 50 mg/1 |
| Pharm Classes | Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
| Marketing Start Date | 2017-02-09 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA202825 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2017-02-09 |
| Marketing Category | ANDA |
| Application Number | ANDA202825 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2017-02-13 |
| Ingredient | Strength |
|---|---|
| SERTRALINE HYDROCHLORIDE | 50 mg/1 |
| SPL SET ID: | 205ecf52-8138-44a7-ad9a-b3aa7f4fa11a |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0143-9580 | Sertraline Hydrochloride | sertraline hydrochloride |
| 0143-9581 | Sertraline Hydrochloride | sertraline hydrochloride |
| 0143-9582 | Sertraline Hydrochloride | sertraline hydrochloride |
| 68071-1317 | Sertraline Hydrochloride | Sertraline Hydrochloride |
| 68071-1318 | Sertraline Hydrochloride | Sertraline Hydrochloride |
| 68071-1976 | Sertraline Hydrochloride | Sertraline Hydrochloride |
| 68071-3071 | Sertraline Hydrochloride | Sertraline Hydrochloride |
| 68071-2162 | Sertraline Hydrochloride | Sertraline Hydrochloride |
| 68071-3146 | Sertraline Hydrochloride | Sertraline Hydrochloride |
| 68071-3309 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE |
| 68071-4029 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE |
| 68071-4370 | Sertraline Hydrochloride | Sertraline Hydrochloride |
| 68071-3379 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE |
| 68071-4658 | Sertraline Hydrochloride | Sertraline Hydrochloride |
| 68071-4750 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE |
| 68071-4494 | Sertraline Hydrochloride | Sertraline Hydrochloride |
| 68071-4462 | Sertraline Hydrochloride | Sertraline Hydrochloride |
| 68084-181 | Sertraline Hydrochloride | Sertraline Hydrochloride |
| 68382-043 | Sertraline Hydrochloride | Sertraline Hydrochloride |
| 68382-045 | Sertraline Hydrochloride | Sertraline Hydrochloride |
| 68387-119 | Sertraline Hydrochloride | Sertraline Hydrochloride |
| 68382-044 | Sertraline Hydrochloride | Sertraline Hydrochloride |
| 68645-523 | Sertraline Hydrochloride | Sertraline Hydrochloride |
| 68645-522 | Sertraline Hydrochloride | Sertraline Hydrochloride |
| 68645-521 | Sertraline Hydrochloride | Sertraline Hydrochloride |
| 68788-6919 | Sertraline Hydrochloride | Sertraline Hydrochloride |
| 68788-6437 | Sertraline Hydrochloride | Sertraline Hydrochloride |
| 68788-6835 | Sertraline Hydrochloride | Sertraline Hydrochloride |
| 68788-6429 | Sertraline Hydrochloride | Sertraline Hydrochloride |
| 68788-7035 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE |
| 68788-6923 | Sertraline Hydrochloride | Sertraline Hydrochloride |
| 68788-7001 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE |
| 68788-9693 | Sertraline Hydrochloride | Sertraline Hydrochloride |
| 68788-9873 | Sertraline Hydrochloride | Sertraline Hydrochloride |
| 68788-9872 | Sertraline Hydrochloride | Sertraline Hydrochloride |
| 69097-157 | Sertraline Hydrochloride | Sertraline Hydrochloride |
| 69097-833 | Sertraline Hydrochloride | Sertraline Hydrochloride |
| 69097-155 | Sertraline Hydrochloride | Sertraline Hydrochloride |
| 69097-156 | Sertraline Hydrochloride | Sertraline Hydrochloride |
| 69097-835 | Sertraline Hydrochloride | Sertraline Hydrochloride |
| 69097-834 | Sertraline Hydrochloride | Sertraline Hydrochloride |
| 70518-0094 | Sertraline Hydrochloride | Sertraline Hydrochloride |
| 70518-0679 | Sertraline Hydrochloride | Sertraline Hydrochloride |
| 70518-1276 | Sertraline Hydrochloride | Sertraline Hydrochloride |
| 70518-1748 | Sertraline Hydrochloride | Sertraline Hydrochloride |
| 70518-1350 | Sertraline Hydrochloride | Sertraline Hydrochloride |
| 70518-1615 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE |
| 70934-176 | Sertraline Hydrochloride | Sertraline Hydrochloride |
| 70934-169 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE |
| 71205-047 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE |